How effective and sustainable are Root. HFESA Conference

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How effective and sustainable are Root Cause Analysis (RCA) investigations 27 th November 2017 HFESA Conference Peter Hibbert, Matthew Thomas, Anita Deakin, Bill Runciman, Jeffrey Braithwaite Acknowledgements: Tanya Surwald, Cathy Fraser, Lorraine Langley, Amy Szczygielski, Stephanie Lomax, Jonathan Prescott, Glenda Gorrie and Victorian Department of Health and Human Services

The brief What are Root Cause Analysis (RCA) reports are telling us about the main risks to patients in the Victorian health system? Are RCAs providing useful information? How effective are the recommendations? Making recommendations based on these findings.

What we did 227 de-identified RCA reports from Sentinel Events (SEs) between 2010-2015; Classified incident type, contributing factors, outcomes, recommendations; Analysis of best practice in the conduct of these RCAs; and Stakeholder feedback (3 focus groups, 18 interviews and a survey with 65 respondents) on the strengths and weaknesses of the RCA process.

Root cause analysis Relatively common technique Time consuming Patients still getting harmed with similar adverse events? return on investment for safety

Today s topics Summary of the types of sentinel events RCA quality analysis Recommendations / way forward

Today s topics Summary of the types of sentinel events RCA quality analysis (recommendations strength and thematic analysis) Recommendations / way forward

Sentinel event analysis Sentinel Event number Sentinel Event descriptor Total 1 Wrong patient / body part 2 2 Inpatient suicide 38 3 Retained surgical instruments/other 30 4 Gas embolism 2 5 ABO incompatible blood transfusion 1 6 Medication error 17 7 Maternal death 8 8 Wrong infant discharged 0 9 Other 129 Total 227

Sentinel Event Category 9 Other, Catastrophic analysis by incident type 87%: Clinical process/procedure, falls, and behaviours (self-harm, suicide) Clinical process/procedures: Diagnosis 27 Procedural complications 22 Other 8 No pressure injuries, no DVTs/PEs

Today s topics Summary of the types of sentinel events RCA quality analysis (recommendations strength and thematic analysis) Recommendations / way forward

Strength of Recommendations Stronger: Simplify the process and remove unnecessary steps Standardise on equipment or process of care-maps Architectural / physical plant changes Intermediate: Increase staffing / decrease workload Checklist / cognitive aid Enhanced documentation / communication Weaker: Double checks Warnings and labels New policy / procedure / training 10

Recommendation strength In the 227 RCAs, there were 1,137 recommendations made, 5.0 (SD 3.1) per RCA. 8% of these were strong ; 48% and 44% were weak and medium respectively. In 15% of RCAs, only weak recommendations were made. in 11% of RCAs, there were five or more weak recommendations. In 72% of RCAs, there were no strong recommendations made. Most frequent recommendation types (65% of all): Reviewing or enhancing a policy/guideline/ documentation Training and education Development of a new procedure/memorandum/policy.

Recommendation strength (%) Recommendation strength Vic NSW (Taitz 2010) New York (Kellogg 2016) Strong 8 5 9 Medium 48 7 41 Weak 44 86 50

Today s topics Summary of the types of sentinel events RCA quality analysis (recommendations strength and thematic analysis) Recommendations / way forward

Narrative analysis of the quality of retained material RCAs: key points 31 RCA reports All associated with retained surgical materials Type of retained material n Surgical packs 9 Drain tubes 8 Vascular devices 4 CVC guide wire 3 Surgical instrument 1 Transvaginal tape - plastic sheath 1 Plastic around a hernia repair mesh 1 Silicon sheet 1 Cholangiogram catheter fragment 1 Cochlear implant stainless steel template 1 Green gauze 1 Total 31

Where improvements could be made Teamwork and communication problems often implied but not explicit Human factors not explicitly mentioned (eg fatigue, skills and knowledge, and environment) Asking broader questions about service structure Using external information to inform the investigation

Today s topics Summary of the types of sentinel events RCA quality analysis (recommendations strength and thematic analysis) Recommendations / way forward

Support, Training, Analysis Improve access to basic RCA training and development Use the US Veteran Affairs Triage Tool Guidance Documentation / Toolkit De-identified composite examples of best practice RCAs

RCA Team composition and interviewing consumers Involve consumers in safety and quality processes and governance committees. Human factors expertise External / independent representation RCA panels should be encouraged to interview consumers when they believe that they potentially have valuable information to contribute about what happened and why.

Gathering information Staff interviews what must have happened vs what did happen; recall bias Reviewing documentation may assume that what is in a written policy reflects what happens day to day. RCA teams may find no systems issues because the policies may be well written and broadly applicable Recommendation: Techniques such as in-situ observations and lowfidelity simulation may help identify work-arounds and organisational structures or processes that influence or constrain behaviours or actions by individuals

Use of other investigation techniques Other methodologies, besides RCAs, such as Failure Mode Effects Analysis (FMEAs) and cluster reviews, may be more suitable for some SEs. Some Australian states do not mandate the type of investigation required for serious incidents, allowing health services to choose.

Resources consumed by common Root Cause Analyses Over half of the SEs analysed in this research were falls, retained instruments or suicides. Undertaking RCAs on each SE is a significant burden for health services. Many of the same contributing factors emerge within each category bringing into question the opportunity cost of undertaking full RCAs on each common SE. Recommendation: DHHS consider researching and developing templates for investigation of falls, suicides and retained materials, and pilot them at health services to facilitate a less resource-intensive process.

Key factors associated with 27 falls Some of these could be combined with elements in falls risk assessment tools to form a falls investigation checklist Significant medical history (19) Cognitive impairment (18) Identified high falls risk (16) Medication involvement (16) Fall assessment not completed or inaccurate/minimisation strategies not implemented (15) Poor communication between staff (inc handover) (8) No documentation re increased risk of falls (inc due to new medication) (7) Problem with equipment (6) Observations (neuro/head/vital signs) inadequate post fall (5) Footwear inadequate (4) Clinical guidelines don t inform practice (4) Inappropriate bed allocation (4) Problem with referral to OT/Physio (3) Review of ordered medication not undertaken (3) Language barrier (2) Cot sides up but contraindicated due to confusion etc (2) Other documentation (excluding falls risk assessment) inadequate (1) Staff working outside of their responsibility (1) Lack of sensitivity, including risk stratification, of falls risk in existing tool (1)

State-wide aggregation of incidents Similar incidents occur across health services Eg two very similar incidents involved Penrose Drains which slipped in the patient s bodies undetected. The drains were being used peri-anally and not being secured with safety pins due to comfort reasons. Recommendation: An increased role for the Departments of Health, by noting the similar mechanisms, analysing these, and potentially initiating state-wide actions to reduce this type of SE occurring again

Thank you Peter Hibbert Australian Institute of Health Innovation Macquarie University Peter.Hibbert@mq.edu.au https://www2.health.vic.gov.au/hospitals-and-health-services/qualitysafety-service/clinical-risk-management/sentinel-event-program